BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2525694 · Received April 10, 2012

    Report

    Report Number
    2939301-2012-03628
    Event Type
    Injury
    Date Received
    April 10, 2012
    Report Date
    March 29, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP (5/21/2012) - DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 5/1/2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. THE 510K # K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THE ONETOUCH ULTRA METER IS GIVING INACCURATE HIGH READING OF 157 MG/DL COMPARED TO FEELINGS/NORMAL READING. BASED ON THE ELEVATED READING, THE PATIENT CONSULTED WITH HIS DOCTOR ADVISED HIM TO INCREASE HIS INSULIN DOSAGE FROM 4 UNITS TO 6 UNITS. REPORTEDLY, THE PATIENT FAINTED AFTER THE INCREASING THE INSULIN DOSAGE. DURING TROUBLESHOOTING, THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION TO CHECK THE CALIBRATION OF THE METER AND TEST STRIPS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE PATIENT TOOK INSULIN BASED ON THE LFS METER READING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening